Recruiting

Verasense

Sponsor:

Nova Scotia Health Authority

Code:

NCT03286868

Conditions

Osteo Arthritis Knee

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Total Knee Arthroplasty

Total Knee Arthroplasty with Verasense sensor

Study Details

Brief summary:

Total Knee Replacement (TKR) is an operation to help with the pain and decreased function that happens with end stage arthritis of the knee. This operation has been shown to be very successful at relieving pain and improving patient mobility; however, some studies have shown that up to 20% of TKR recipients are not happy with their knee replacement.

All of the reasons why some patients are not pleased with the outcome of surgery are not known, but one of the possible causes is the way the implants are placed, or aligned, during surgery. Most TKRs are aligned in a fashion that the bones in the leg are completely straight after surgery. This is known as mechanically aligning a TKR. A different alignment method known as kinematic alignment respects the natural bow legged or knock kneed alignment of the patient. It is hoped that kinematically aligning a knee replacement will improve how the knee feels to the patient and therefore improve their satisfaction.

Another potential factor affecting the outcomes of TKR is obtaining optimal soft tissue balance. The challenge with balancing a TKR is that traditional operative techniques rely on subjective feel of the knee stability during surgery. The balance or tension in the knee can however be objectively measured using specialized intraoperative pressure sensing devices.

The purpose of this study is to assess the impact of kinematically aligned TKR on the pressures measured by Verasense during total knee replacements. The study will also determine if differences in the pressure measured during TKR surgery impact patient outcomes after surgery.

Conditions

Osteo Arthritis Knee

Study ID

NCT03286868

Start date

Jul 23, 2018

Status verified date

Jan, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Symptomatic arthritis of the knee indicating primary total knee arthroplasty
  • Between the ages of 21 and 80 inclusive
  • Patients willing and able to comply with follow-up requirements and self-evaluations
  • Ability to give informed consent
  • Varus alignment

Exclusion Criteria:

  • Patients less than 21 years of age, or 81 years of age and older
  • Unable to provide consent
  • BMI >45
  • Pregnancy
  • Patients with inflammatory arthritis, posttraumatic osteoarthritis, post high tibial osteotomy, or arthritis due to sepsis will be excluded.
  • Active or prior infection
  • Medical condition precluding major surgery
  • Severe osteoporosis or osteopenia
  • Neuromuscular impairment
  • Significant co-morbidity affecting ability to ambulate
  • Valgus alignment

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Standard of Care TKA

Standard of Care Total Knee Arthroplasty (TKA): No data from the Verasense sensor will be used to influence the surgery

experimental: TKA with Verasense sensor

Total Knee Arthroplasty (TKA) with Verasense sensor for Intraoperative Balancing: Surgeon will attempt to optimize the intraoperative pressures using the data from the Verasense sensor

Interventions

Total Knee Arthroplasty

Total Knee Arthroplasty

Total Knee Arthroplasty with Verasense sensor

Total Knee Arthroplasty with Verasense sensor

Primary outcome measure

  • gait assessment [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Contacts

Elise Laende

902-473-3883

Principal Investigator:

Michael Dunbar

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Feb 17, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2025-02-17.